Cannabidiol and CES1 Interactions in Healthy Subjects
Study Details
Study Description
Brief Summary
The proposed study will assess the drug interaction potential between oral cannabidiol (Epidiolex®) and the carboxylesterase 1 (CES1) substrate methylphenidate (Ritalin®) in 12 healthy research subjects
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Exposure A Subjects will be administered one (1) 10 mg tablet of dl-methylphenidate (Ritalin®) CBD 750 mg (administered as 7.5 ml of Epidiolex® solution [100 mg/ml] of CBD) |
Drug: di-Methylphenidate plus Cannabidiol
Subjects will be administered one (1) 10 mg tablet of dl-methylphenidate (Ritalin®) plus CBD 750 mg (administered as 7.5 ml of Epidiolex® solution [100 mg/ml] of CBD)
Other Names:
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Active Comparator: Exposure B Subjects will be administered one (1) 10 mg tablet of dl-methylphenidate (Ritalin®) 7.5 ml of Epidiolex® placebo solution containing no CBD. |
Drug: di-Methylphenidate plus Cannabidiol Placebo solution
Subjects will be administered one (1) 10 mg tablet of dl-methylphenidate (Ritalin®) 7.5 ml of Epidiolex® placebo solution containing no CBD.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Differences in the geometric mean ratios (GMR) of the pharmacokinetic parameters will be compared between the two exposure conditions; i.e. methylphenidate + CBD vs methylphenidate + placebo. [8 hours for each exposure condition for pharmacokinetic assessments]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Signed Informed Consent
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Age: 21-45 years
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Gender: males and females (50:50)
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Race or ethnicity: no restrictions
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Body Mass Index (BMI) between 18.5 to 28 kg/m2 (inclusive)
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Satisfactory completion of the screening medical history, physical exam, and laboratory evaluations.
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Females of child-bearing potential must have a negative urine pregnancy test prior to enrollment and avoid pregnancy during study participation.
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With the exception of oral contraceptives, subjects must not be taking prescription or OTC medication for the duration of study participation
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Subjects must have no ongoing use of any botanical/nutritional supplement, vitamin, or energy drink for the duration of study participation
Exclusion Criteria:
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The presence of a known allergy, hypersensitivity, or adverse reaction to CBD or cannabis, or sesame seed oil
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The presence of a known allergy, hypersensitivity, or adverse reaction to methylphenidate or dexmethylphenidate (Focalin®)
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A history (within the past year) or presence of clinically significant cardiovascular, cerebrovascular, renal, hepatic, gastrointestinal, pulmonary, immunological, hematological, endocrine, or neurologic disease will render subjects ineligible for the study.
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The presence of any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion including;
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Gastric bezoar
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Swallowing disorders
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Strictures
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Fistulas
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GI obstruction
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Severe dsyphasgia
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Crohn's disease
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Diverticulitis
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A positive urine pregnancy test.
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A positive Urine Drug Screen
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Any concomitant prescription medication, OTC medication, herbal or other dietary supplement or vitamins during the study period.
All subjects must be medication-free from 7 Days before initiation of the first active study day, through the duration of the study. This exclusion the use of vitamins, herbal preparations and OTC supplements.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of Florida | Gainesville | Florida | United States | 32610 |
Sponsors and Collaborators
- University of Florida
- State of Florida Consortium for Medical Marijuana Clinical Outcomes Research
Investigators
- Principal Investigator: John Markowitz, Pharm.D, University of Florida
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB202002547-A
- OCR39758